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This article was originally published in The Tan Sheet

Executive Summary

ASTHMA WARNING DROPPED FOR ANTIEMETIC AND SLEEP AID PRODUCTS containing antihistamine ingredients, such as diphenhydramine, under a proposed amendment to the antiemetic and nighttime sleep aid drug products final monographs published in the Aug. 26 Federal Register. FDA explained that it decided to drop the asthma warning for antiemetics and sleep aids containing antihistamine ingredients to make the warning statements consistent with the antihistamine monograph. In the December 1992 antihistamine final monograph, FDA removed an asthma contraindication from the warning statement at the recommendation of FDA's Pulmonary-Allergy Advisory Committee. In June 1990, the committee advised that a warning statement for both OTC and Rx antihistamine labeling that contraindicates use in asthma patients should be removed "as soon as possible." A National Heart, Lung & Blood report issued in February 1991 echoed the advisory committee recommendation, noting that "the long-held concern" about an adverse drying effect of antihistamines on bronchial mucus was no longer valid. The asthma contraindication also was removed from warnings required by the antitussive monograph. FDA noted that the proposal aligns the warning for OTC antiemetics with that for antihistamines. "Diphenhydramine and the other active ingredients in the antiemetic monograph (cyclizine hydrochloride, dimenhydrinate and meclizine hydrochloride)," FDA pointed out, are also classified as antihistamines. Moreover, the agency said, using the same warning for OTC nighttime sleep aids "will ensure that warnings are the same for diphenhydramine salts [diphenhydramine citrate or hydrochloride] whether the ingredient is used in OTC nighttime sleep aid, antihistamine, or antitussive drug products." The proposed revised warning for antiemetics and nighttime sleep aids reads: "Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland." Current labeling for OTC antiemetics and nighttime sleep aids warns against their use by individuals who suffer from asthma, glaucoma, emphysema, chronic pulmonary disease, shortness of breath, difficulty in breathing, or difficulty in urination due to enlargement of the prostate gland. The same warning was initially proposed in the tentative final monograph for OTC antihistamines in 1985, but was revised in the 1992 antihistamine final monograph to include the broader phrase "breathing problems" to "describe symptoms such as shortness of breath and difficulty in breathing related to obstructive pulmonary disease," FDA explained. The change allows "consumers to recognize respiratory distress symptoms more readily," FDA added. The agency also replaced the term "chronic pulmonary disease" with "chronic bronchitis." An additional warning proposed for OTC antiemetics but not for OTC nighttime sleep aids instructs consumers not to "give this product to children who have a breathing problem such as chronic bronchitis or who have glaucoma, without first consulting the child's doctor." The same warning, which should be used on products labeled for use exclusively by children, was also proposed for OTC antihistamines and antitussives. FDA is accepting comments on both the antiemetic and nighttime sleep aid proposals until Oct. 25.

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